Role & responsibilities

Engineering QMS profile :

- Maintain Engineering QMS documentation, including SOPs, formats, checklists, logbooks, records, and controlled documents.

- Manage Engineering logbook stock, issuance, reconciliation, and archival as per document-control requirements.

- Control issuance and retrieval of approved Engineering formats and ensure availability of current versions at point of use.

- Ensure proper documentation, review, completeness, and traceability of Engineering records.

- Coordinate document preparation, revision, approval, effective-date implementation, and obsolescence of Engineering documents.

- Maintain records related to preventive maintenance, breakdown maintenance, calibration, utilities, HVAC, water systems, and critical equipment.

- Support Change Control, Deviation, CAPA, Risk Assessment, Qualification/Validation, and audit-related documentation.

- Ensure timely closure of Engineering documentation gaps, deviations, CAPAs, and audit observations.

- Support GMP, regulatory, customer, and internal audits by maintaining Engineering records and ensuring QMS readiness.

- Promote Positive Documentation Practices (GDP), data integrity, and compliance across Engineering activities.

📌 Executive / Senior Executive_Engineering QMS For Injectable plant (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad